(54 days)
Not Found
No
The summary describes a sterile, disposable sheath for endoscopes and does not mention any AI/ML capabilities or image processing.
No.
The device acts as a protective covering for an endoscope and eliminates the need for high-level disinfection; it does not directly treat or diagnose a medical condition.
No
The device is described as a protective covering for a scope during endoscopic examination, eliminating the need for disinfection. Its function is to facilitate the examination by protecting the scope, not to diagnose a condition itself.
No
The device is a sterile, disposable sheath, which is a physical, hardware component. The description focuses on its physical properties and performance as a barrier, not on software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to serve as a protective covering for an endoscope during examination of the upper airway, vocal chords, and nasal passages. This is a direct medical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a sterile, disposable sheath designed to fit an endoscope. This aligns with a device used during a medical procedure, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely protective and procedural.
N/A
Intended Use / Indications for Use
The Vision-Sciences EndoSheaths® are indicated for use as a protective covering for the scope during endoscopic examination of the upper airway, vocal chords and/or nasal passages.
The EndoSheath® provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
Product codes
77 EOB
Device Description
The devices described in this 510(k) are sterile, disposable, sheaths designed to fit a variety of nasolaryngoscopes. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airway, vocal chords and/or nasal passages
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Validation testing including microbial barrier testing, tensile/elongation testing, leak testing, sheathed scope articulation testing and sheathed scope image quality evaluation is included in Design Validation and Verification planning.
Key Metrics
Not Found
Predicate Device(s)
K950809, K961591, K933247, K925421, K921244
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Vision-Sciences has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Special 510(k) Premarket Notification: Device Modification
Modified EndoSheath® for Flexible E
510(k) Summary
| Trade Name: | Vision-Sciences EndoSheaths® for use with Flexible ENT Scopes |
|---|---|
| Sponsor: | Vision-Sciences, Inc. |
| 9 Strathmore Road | |
| Natick, MA 01760 | |
| Resistration #1223490 | |
| Device Generic Name: | Protective sheath for endoscope |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. | |
| Predicate Devices: | K950809 - Modified ENT EndoSheaths® |
| K961591 - EndoSheath® for E-F100 ENT Scope | |
| K933247 - ENT EndoSheath® | |
| K925421 - ENT EndoSheath® | |
| K921244 - ENT EndoSheath® | |
| Manufactured by: | Vision-Sciences, Inc. |
| 9 Strathmore Road | |
| Natick, MA 01760 |
Product Description: The devices described in this 510(k) are sterile, disposable, sheaths designed to fit a variety of nasolaryngoscopes. The use of an EndoSheath® eliminates the need for high-level disinfection of the scope following each procedure.
Indications for Use:
The Vision-Sciences EndoSheaths® are indicated for use as a protective covering for the scope during endoscopic examination of the upper airway, vocal chords and/or nasal passages.
Safety and Performance:
This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Vision-Sciences has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. Validation testing including microbial barrier testing, tensile/elongation testing, leak testing, sheathed scope articulation testing and sheathed scope image quality evaluation is included in Design Validation and Verification planning.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the modified EndoSheaths® for use with Flexible ENT scopes have been shown to be safe and effective for their intended use.
1
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 1999
Pamela Papineau Consultant to Vision-Science, Inc. Vision Sciences, Inc. 6 Strathmore Road Natick, MA 01760
Re: K990354 Trade Name: EndoSheath ® for use with Flexible ENT Scope Regulatory Class: II Product Code: 77 EOB Dated: March 16, 1999 Received: March 17, 1999
Dear Ms. Papineau:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
2
Page 2 - Ms. Pamela Papineau
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: __ EndoSheath® for use with Flexible ENT Scopes
Indications for Use:
The EndoSheath® provides a sterile, disposable protective covering for the scope to be used during flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the -Counter Use
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K990354
Karen Bohn (for HRS)